Study
| A single-arm, multicenter, phase 2 study |
| Advanced/metastatic unresectable iCCA harboring FGFR2 gene fusions |
| Disease progression after ≥1 line of systemic therapy |
| Futibatinib 20 mg QD until disease progression/unacceptable toxicity ( n=103) |
Efficacy
| ORR: 42 % [32.0-52.0] |
| mDoR: 9.7 mos [7.6-17.1 mos] |
Safety
| Any grade AEs: hyperphosphatemia (79.1%), diarrhea (37.3%), dry mouth (32.8%) |
| Grade ≥3 AEs: hyperphosphatemia (25.4%) |
| Treatment related death: 2 patients |
FDA package insert
http://www.ncbi.nlm.nih.gov/pubmed/0
Reviewed by Elvin Chalabiyev, MD on Jan 10, 2023
